MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ TRUE SIZE THERMODILUTION CATHETER; CATHETER, FLOW DIRECTED

Model Number TS105F5

Device Problem Inflation Problem (1310)

Patient Problem Great Vessel Perforation (2152)

Event Date 07/11/2023

Event Type  Death  

Event Description

It was reported that during use, with a swan-ganz catheter, the patients pulmonary artery was ruptured when trying to wedge the catheter.The syringe used to inflate the balloon was said to be the syringe that came with the kit.The customer states labeling indicated 1.5ml of air but the device indicates.8ml of air.It is unknown how much air was introduced into the balloon.It is unknown whether the swan was able to be wedged.The customer also stated that the plunger came out of the syringe.The pulmonary artery was diagnosed when the patient started coughing up blood and the cet of the chest confirmed the diagnosis.The patient was coded, intubated and a central line was placed.Six days after the patient was diagnosed with a pulmonary rupture, the patient expired.

Manufacturer Narrative

The device will not be returned for evaluation as it was discarded at the facility.Without the return of the unit, it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.A device history record review was unable to be completed as the lot number is unknown.Per the instructions for use, pulmonary artery perforation is a known potential adverse event which has been identified as a possible complication of the use of pulmonary artery catheters, such as the swan-ganz.There are multiple patient and procedural factors that alone or in combination can cause or contribute to pulmonary artery perforation, including: pulmonary hypertension, advanced age, cardiac surgery with hypothermia and anticoagulation, distal catheter tip migration, arteriovenous fistula formation and other vascular traumas.Extreme care should therefore be exercised during the measurement of pulmonary artery wedge pressure in patients with pulmonary hypertension.In all patients, balloon inflation should be limited to two respiratory cycles.A central location of the catheter tip near the hilum of the lung may prevent pulmonary artery perforation.Early clinical symptoms of a pulmonary artery perforation include hemoptysis of bright red blood and or hypotension.The ifu has been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions or conditions for the successful use of the device.Complaint histories for all reported events are reviewed through trending on a monthly basis and continue to be monitored for any unfavorable trends and documented as part of this monthly review.No corrective or preventative actions are required at this time.H3 other text: device not returned.

Manufacturer Narrative

An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.There were no manufacturing non-conformances found with the device.The customer stated that the device labeling indicated 1.5ml of air but the device indicates.8ml of air.However, this model does not indicate the inflation capacity on the device.The kiting for the device includes a 1ml syringe with 0.1ml graduation, along with a single sheet specification document that highlights the important parameters the physician needs to know to insert and place the catheter safely, including the balloon inflation capacity (0.8ml).There is a paper booklet ifu included with the kit that provides general instructions across multiple models, and on page 3 it states to inflate to the recommended volume printed on the catheter shaft and does include (1.5ml) as an example.It also contains a warning: pulmonary complications may result from improper inflation technique.To avoid damage to the pulmonary artery and possible balloon rupture, do not inflate above the recommended volume.Use the volume limited syringe provided in the catheter package.The risk for this issue has been assessed and remains within predicted limits.The complaint rate for the product family was calculated at (b)(4) percent with over one million units in the product family distributed, and this has been the only complaint recorded for this issue in at least 8 years.A corrective and preventive actions (capa) was generated to further investigate and implement improvements.This capa is currently in the investigation phase.Multiple follow up attempts were made with the facility for medical records and a physician to physician call, but the facility declined both.Corrected data: updates to the h6 codes are as follows: component code updated to catheter.

• Brand Name: SWAN-GANZ TRUE SIZE THERMODILUTION CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: katheryn richards ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 18156625
• MDR Text Key: 328350013
• Report Number: 2015691-2023-17569
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K810124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TS105F5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/27/2023
• Initial Date FDA Received: 11/16/2023
• Supplement Dates Manufacturer Received: 01/19/2024
• Supplement Dates FDA Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 79 KG